Effects of Vitamin D3 Supplementation on Cognitive Function in Community Dwelling Older Adults

Sponsor

University of Dublin, Trinity College (Other)

Overall Status

Completed

CT.gov ID

NCT02804841

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Ireland is predicted to have the highest older adult population growth of any European Union country. A substantial economic and social challenge of this projected growth is the increased incidence of cognitive impairment and the likelihood of progression to dementia. Dementia's, such as Alzheimer's disease, typically have a long prodromal stage with brain changes identifiable from the earliest stages of neuropathology, providing an opportunity for intervention. Switching to a strategy of earlier identification and prevention would significantly reduce prevalence and the associated cost.

The purpose of this pilot study is to evaluate the use of vitamin D supplements in community dwelling older adults as a lifestyle approach that may support cognitive and physical functioning. The research will incorporate several stages including an initial in-depth screening process, a novel and sensitive cognitive battery, 6 month double blind placebo controlled intervention of vitamin D3 (cholecalciferol) and a concluding participant feedback interview.

These results will be used to assess the feasibility of recruiting and assessing community dwelling older adults for extensive nutrition related cognitive studies.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Dietary Supplement: Cholecalciferol -Vitamin D3 Other: Placebo -gel capsule containing no vitamin D.	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Prevention

Official Title:

D-activating Decline- Exploring the Effects of Vitamin D3 Supplementation on Cognitive Function in Community Dwelling Healthy Older Adults- A Pilot Study

Study Start Date :

Nov 1, 2015

Actual Primary Completion Date :

May 1, 2016

Actual Study Completion Date :

Nov 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Healthy, Community Dwelling; Aged 60-80 years; Cholecalciferol -Vitamin D3, 4000 international units (IU) on alternating days.	Dietary Supplement: Cholecalciferol -Vitamin D3
Placebo Comparator: Placebo Healthy, Community Dwelling; Aged 60-80 years; Placebo -gel capsule containing no vitamin D on alternating days.	Other: Placebo -gel capsule containing no vitamin D.

Arm

Intervention/Treatment

Experimental: Intervention

Healthy, Community Dwelling; Aged 60-80 years; Cholecalciferol -Vitamin D3, 4000 international units (IU) on alternating days.

Dietary Supplement: Cholecalciferol -Vitamin D3

Placebo Comparator: Placebo

Healthy, Community Dwelling; Aged 60-80 years; Placebo -gel capsule containing no vitamin D on alternating days.

Other: Placebo -gel capsule containing no vitamin D.

Outcome Measures

Primary Outcome Measures

Global Cognitive Function [26 weeks]
Global cognitive function will be assessed using the validated Montreal Cognitive Assessment for all participants
Executive Function [26 weeks]
Executive function will be assessed according to the validated Trails Making Task Part A and B
Memory [26 weeks]
Episodic memory will be assessed according to the Wescher Memory Scale
Attention and Visual Reasoning [26 weeks]
Attention and visual memory will be assessed using 2 validated measures: the Sustained Attention to Response Task and the Cambridge Mental Disorders of the Elderly Examination Visual Reasoning Test

Secondary Outcome Measures

Muscle strength [26 weeks]
Muscle strength in the participants will be assessed using a clinical dynamometer to measure grip strength
Physical function [26 weeks]
Physical function will be assessed using the Timed up and Go measure
Systemic inflammation [26 weeks]
Serum will be analysed for levels of specific cytokines
Change in Blood Level of Vitamin D (25-hydroxyvitamin D) [0, 12 and 26 weeks]
Serum will be analysed for change in levels from baseline

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Community Dwelling healthy volunteers
Ability to provide written consent.

Exclusion Criteria:

Measures low or high serum vitamin D, defined as < 15nmol/L or >125nmol/L
Current use of supplemental vitamin D ≥800 international units/d
Screen positive for cognitive impairment using the Telephone Cognitive Screen (TCogS)
Measured hypercalcaemia, defined as corrected serum calcium > 2.7nmol/l
Hyperparathyroidism
Epilepsy
Stroke
Renal disease
Schizophrenia
Bipolar affective disorder
Recurrent psychotic depression
Alcohol and drug abuse within the past 5 years
Anti-convulsants
Anti-psychotic medications
Significant hearing difficulties even when wearing hearing aid
Illness that caused permanent decrease in memory or other mental function

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Dublin, Trinity College	Dublin		Ireland

Sponsors and Collaborators

University of Dublin, Trinity College

Investigators

Principal Investigator: Maria O'Sullivan, PhD, The University of Dublin, Trinity College
Principal Investigator: Brian Lawlor, MD, The University of Dublin, Trinity College